Home NDC 64980-509 Dexamethasone
Product NDC 64980-509
11-digit product format 649800509
Labeler code 64980
Product ID 64980-509_0bde0d4d-9482-444f-8fa2-07344fc0e5ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone
Dosage form ELIXIR
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA090891
Marketing category ANDA
Marketing start 2011-08-01
Substance DEXAMETHASONE
Active strength .5 mg/5mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090891-001 DEXAMETHASONE DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090891-001 AA
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090891-001 DEXAMETHASONE 0.5MG/5ML ELIXIR / ORAL AA 2011-07-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE .5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7S5I7G3JQL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309686 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-509-24 Dexamethasone 237 mL in 1 BOTTLE, PLASTIC ELIXIR 237 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dexamethasone ACTIVE INGREDIENT 7S5I7G3JQL DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 Dexamethasone ACTIVE MOIETY 7S5I7G3JQL DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 SUCROSE INACTIVE INGREDIENT C151H8M554 DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R DEXAMETHASONE ELIXIR [RISING PHARMACEUTICALS, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-509 DEXAMETHASONE ELIXIR [RISING PHARMA HOLDINGS, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20250205_7cf5c17c-a80b-4547-83b2-0d53e2b933f7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-509-24 64980050924 237 mL in 1 BOTTLE, PLASTIC (64980-509-24) 237 ml 2011-08-01 0000-00-00 No No Current